Ambu aScope RLS Slim
K-Number: K181286 · 2018-11-30
ApplicantAmbu A/S
Decision Date2018-11-30
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Ambu aScope RLS Slim is a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2018-11-30 under approval number K181286. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambu aScope RLS Slim?
Ambu aScope RLS Slim is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Ambu A/S. The 510(k) number is K181286.
When was Ambu aScope RLS Slim approved by the FDA?
Ambu aScope RLS Slim received FDA 510(k) clearance on 2018-11-30, under approval number K181286.
What company makes Ambu aScope RLS Slim?
Ambu aScope RLS Slim is manufactured by Ambu A/S.
What is the FDA product code for Ambu aScope RLS Slim?
The FDA product code for Ambu aScope RLS Slim is EOB.
Other Devices by Ambu A/S
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K160766Ambu USR, Ambu M
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K190972Ambu aScope 4 RhinoLaryngo Intervention
K191080Ambu aScope 4 RhinoLaryngo Slim
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.